NDC 67457-455

cytarabine

Cytarabine

cytarabine is a Intrathecal; Intravenous; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Cytarabine.

Product ID67457-455_0da3265a-9e68-40b4-869e-121b782b3d98
NDC67457-455
Product TypeHuman Prescription Drug
Proprietary Namecytarabine
Generic NameCytarabine
Dosage FormInjection
Route of AdministrationINTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2011-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA200915
Labeler NameMylan Institutional LLC
Substance NameCYTARABINE
Active Ingredient Strength100 mg/5mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67457-455-52

10 VIAL in 1 CARTON (67457-455-52) > 5 mL in 1 VIAL (67457-455-00)
Marketing Start Date2011-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-455-00 [67457045500]

cytarabine INJECTION
Marketing CategoryANDA
Application NumberANDA200915
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-12-14

NDC 67457-455-52 [67457045552]

cytarabine INJECTION
Marketing CategoryANDA
Application NumberANDA200915
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-12-14

Drug Details

Active Ingredients

IngredientStrength
CYTARABINE100 mg/5mL

OpenFDA Data

SPL SET ID:ee6decae-7e1b-45cf-b2d0-c15946d8fa1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1731355

    • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]
    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]

    NDC Crossover Matching brand name "cytarabine" or generic name "Cytarabine"

    NDCBrand NameGeneric Name
    61703-303CYTARABINECYTARABINE
    61703-304CytarabineCYTARABINE
    61703-305CytarabineCYTARABINE
    61703-319CytarabineCYTARABINE
    63323-120CytarabineCYTARABINE
    67457-452CytarabineCytarabine
    67457-454CytarabineCytarabine
    67457-455cytarabinecytarabine
    68083-337CytarabineCytarabine
    68083-343CytarabineCytarabine
    71288-108CytarabineCytarabine
    71288-109CytarabineCytarabine
    71288-168CytarabineCytarabine
    71288-169CytarabineCytarabine
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